September 2016 FDA Recall Drug by Moore's Compounding Pharmacy
D-0488-2017 - Superpotent Drug and Subpotent Drug; potency failures obtained
This Class II drug recall was voluntarily initiated by Moore's Compounding Pharmacy on September 12, 2016 for the product Drug. The FDA reported the reason for recall as superpotent drug and subpotent drug; potency failures obtained. The product was distributed in TX and the recall is currently terminated.
Recall Number: D-0488-2017
Superpotent Drug and Subpotent Drug; potency failures obtained
09-12-2016
03-01-2017
90 capsules
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
MOORE'S COMPOUNDING PHARMACY
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
TX
05-17-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottles, Rx only, Moore's Pharmacy Compounding, Corpus Christi, TX
Batch or Lot Expiration Information
Lot# 2016-08-22:37@28, exp 2/18/2017
